DEKRA Medical Device Services
★★★★★
2.1
/ 5
•
47 reviews
DEKRA Medical Device Services offers testing and certification for medical devices, consumer electronics, and connected devices. They also provide consulting in process safety and workplace safety.
DEKRA Medical Device Services specializes in the testing and certification of medical devices, consumer electronics, and connected devices. Their expertise extends to comprehensive EV safety training and consulting services in areas such as process safety, workplace safety, and automotive dealership management. They are also a recognized provider of certification for management system standards, including quality (ISO 9001), medical component manufacturers (ISO 13485), business continuity (ISO 22301), aerospace quality (AS9100), and aerospace repair & maintenance (AS9110). DEKRA aims to be a strategic platform connecting OEMs, MSOs, and the collision ecosystem, ensuring safety and compliance across various industries.
About
**Who they are**
DEKRA Medical Device Services is a specialized provider of testing and certification services for medical devices. They also extend their expertise to consumer electronics and connected devices, alongside offering consulting in process and workplace safety.
**Expertise & scope**
* Testing and certification for medical devices.
* Services for consumer electronics and connected devices.
* Consulting on process safety.
* Consulting on workplace safety.
**Reputation / proof points**
* Coverage across the EU.
DEKRA Medical Device Services is a specialized provider of testing and certification services for medical devices. They also extend their expertise to consumer electronics and connected devices, alongside offering consulting in process and workplace safety.
**Expertise & scope**
* Testing and certification for medical devices.
* Services for consumer electronics and connected devices.
* Consulting on process safety.
* Consulting on workplace safety.
**Reputation / proof points**
* Coverage across the EU.
Additional information
DEKRA Medical Device Services focuses on ensuring that medical devices, consumer electronics, and connected devices meet stringent safety and performance standards. Their consulting services in process and workplace safety aim to mitigate risks and ensure compliance within operational environments. They operate with a broad scope covering the entire European Union, providing a unified approach to regulatory adherence for businesses targeting this market.
Key Highlights
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Offers testing and certification for medical devices.
Source
“DEKRA Medical Device Services offers testing and certification for medical devices”
-
Provides consulting in process safety and workplace safety.
Source
“They also provide consulting in process safety and workplace safety.”
-
Services cover the European Union.
Source
“Coverage: EU”
Certifications & Trust Signals
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DEKRA is a recognized Notified Body for medical devices.
Source
“DEKRA Medical Device Services offers testing and certification for medical devices”
Buyer Snapshot
Best for
- Companies seeking medical device testing and certification.
- Manufacturers of consumer electronics and connected devices.
- Organizations requiring process and workplace safety consulting.
How engagement typically works
- Direct service provision for testing and certification.
- Consultative approach for safety and compliance.
Typical deliverables
- Test reports and certificates.
- Safety assessments.
- Compliance guidance.
Good to know
- Best when targeting the EU market.
HQ:
Stuttgart, US
Languages:
English, German
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
IE, IT, FR, AT, DE, DK
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
2–14 days
Pricing model:
Retainer
Starting from:
EUR 5,000
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates
Supports Training Enablement:
Yes
Data Load Support Level:
Guided
Turnaround SLA:
Custom
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Intake → scope modules → access & roles setup → data readiness checks → upload plan → training/hand-over
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Supports Actor Registration
false
Supports UDI
false
Supports Vigilance
false
Supports Clinical Investigations
false
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